NCT02691442

Brief Summary

Several reports have compared the duration of action of levobupivacaine and ropivacaine as local anesthetic. The most widely used method for sensory function evaluation is though means of a pinprick test. The investigators want to use the novel method of Quantitative Sensory Testing to better evaluate the anesthetic activity. This method used hot and cold sensation to assess small nerve fiber function. The investigators will assess the duration of action of different drugs when used in an inter scalene nerve block in patients scheduled for shoulder surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

5 years

First QC Date

February 1, 2016

Last Update Submit

August 11, 2016

Conditions

Other Peripheral Nerve Disease

Keywords

Peripheral nerve block

Outcome Measures

Primary Outcomes (1)

  • Length of nerve block measured in longitudinally recorded significant changes in sensory thresholds using quantitative sensory testing

    Length of difference in cold and heat pain and sensation measured with quantitative sensory testing

    24 hours after intervention

Secondary Outcomes (3)

  • Need for rescue drugs, as requested by the patient after surgery

    24 hours after intervention

  • Motor activity block, longitudinally recorded inability to move the blocked limb

    24 hours after intervention

  • Intensity of nerve block, recorded as maximal changes in sensory thresholds using quantitative sensory testing

    24 hours after intervention

Study Arms (3)

Ropivacaine 0.75%

ACTIVE COMPARATOR

The investigators administer 5 milliliters of Ropivacaine 0.75% in the inter scalene space

Drug: Ropivacaine 0.75%

Levobupivacaine 0.5%

ACTIVE COMPARATOR

The investigators administer 5ml of Levobupivacaine 0.5% in the inter scalene space

Drug: Levobupivacaine 0.5%

Levobupivacaine 0.5% + epinephrin

ACTIVE COMPARATOR

The investigators administer 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in the inter scalene space

Drug: Levobupivacaine 0.5% + epinephrin 1/200000

Interventions

Ropivacaine 0.75%DRUG

The investigators adminster 5ml of Ropivacaine 0.75% in an ultrasound-guided inter scalene nerve block

Also known as: Naropin
Ropivacaine 0.75%
Levobupivacaine 0.5%DRUG

The investigators adminster 5ml of Levobupivacaine 0.5% in an ultrasound-guided inter scalene nerve block

Also known as: Chirocaine
Levobupivacaine 0.5%
Levobupivacaine 0.5% + epinephrin 1/200000DRUG

The investigators adminster 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in an ultrasound-guided inter scalene nerve block

Also known as: Chirocaine
Levobupivacaine 0.5% + epinephrin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesia class I or II
  • Scheduled for shoulder surgery

You may not qualify if:

  • Mental retardation
  • Allergy for local anesthetics
  • NSAID intolerance or contraindicated
  • Diabetes mellitus
  • Chronic use of pain killers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sermeus LA, Schepens T, Hans GH, Morrison SG, Wouters K, Breebaart MB, Smitz CJ, Vercauteren MP. A low dose of three local anesthetic solutions for interscalene blockade tested by thermal quantitative sensory testing: a randomized controlled trial. J Clin Monit Comput. 2019 Apr;33(2):307-316. doi: 10.1007/s10877-018-0150-3. Epub 2018 May 3.

    PMID: 29725795DERIVED

MeSH Terms

Interventions

RopivacaineLevobupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesBupivacaine

Study Officials

  • Luc Serieus, MD

    University Hospital, Antwerp

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 25, 2016

Study Start

December 1, 2010

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

August 15, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share